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Anti-seizure drug gets boxed warning of potential vision loss

FDA has approved a new boxed warning for the anti-seizure drug ezogabine (Potiga) of the potential risk of vision loss, retinal abnormalities, as well as skin, nail, mucous membrane, and sclera discoloration. The agency recommends that ezogabine use be limited to individuals who have not responded to alternative therapies for seizure control, and when the benefits of treatment are greater than the risks.
FDA had issued a safety warning about these risks in April.
FDA also recommends that patients’ visual acuity be tested prior to treatment with ezogabine and every 6 months while undergoing treatment with the anti-seizure drug. If visual acuity or retinal abnormalities are evident, treatment with ezogabine should be stopped. Also, if pigmentary changes occur in the skin, an alternative drug to control seizures should be considered.
The current Risk Evaluation and Mitigation Strategy (REMS) for ezogabine will be updated with the latest boxed warning, FDA said.
Article from http://drugtopics.modernmedicine.com/drug-topics/news/anti-seizure-drug-gets-boxed-warning-potential-vision-loss
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For nearly 20 years, Pharma Logistics has been helping retail pharmacies and hospitals maximize credit value for expired pharmaceuticals and stay compliant with federal and state regulations for disposal. To learn more about our pharmaceutical returns or waste management service, call us today at (888) 729-7427. Our three-step returns system and our highly trained staff makes the pharmaceutical returns process quick and easy.
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FDA hopes hospitals will switch to newly regulated pharmacies

Maggie Fox, NBC News
The Food and Drug Administration hopes hospitals and clinics will vote with their pocketbooks, buying supplies from pharmacies regulated under new powers just given to the agency.
Congress passed a law last month giving the FDA authority to regulate some so-called compounding pharmacies. The aim is to have some oversight over operations that are far bigger than the small pharmacies that make medicines to order.
FDA demanded the changes after a fungal meningitis outbreak last year that killed 64 people and sickened more than 750 others across the country. The outbreak was traced to contaminated drugs sold by a single pharmacy – the New England Compounding Center in Massachusetts.
NECC was an example of a new type of compounding pharmacy – one that made specialized drugs on a large scale and shipped them all over the country. States are supposed to regulate compounding pharmacies, but the laws were written to cover small, mom-and-pop-type operations. The new compounders more closely resemble drug manufacturers, but were not subject to the same FDA oversight as manufacturers.
The new law gives the compounders some leeway but the FDA hopes the marketplace will eventually bring them into line.
“If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others,” FDA commissioner Dr. Margaret Hamburg writes in a blog post discussing the new powers.
“To that end, we will be encouraging health care providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk-based inspections.”
"The more that register, the less need there would be to buy from facilities that are not registered," Jane Axelrad, associate director for policy for the FDA's Center for Drug Evaluation and Research, told reporters in a conference call.
The law isn’t perfect, in FDA's eyes. "It will be difficult for us to identify compounding pharmacies that choose not to register with us," Axelrad said. "We will not be able to do proactive inspections and will have to wait until we have a complaint."
State boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding.
The law also provides for labeling of certain prescription drugs so they can be traced more easily.
“Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date,” Hamburg wrote.
The FDA doesn't know how many compounding pharmacies there are, but estimates anywhere between 700 and 1,000 are in business.
Some of the people infected in the fungal meningitis outbreak are still ill, and several state prosecutors are considering legal action against NECC and its owners.
FDA investigators have found vials of steroids used for back and joint pain injections were contaminated with at least two species of fungus, as well as bacteria. Patients being treated for back pain had these contaminated drugs injected right into their spines, where the fungus grew slowly, eventually spreading into spinal fluid and causing vague symptoms such as headache and fever.
A federal grand jury in Boston has been investigating the New England Compounding Center for more than a year. FDA inspections since the outbreak have turned up cleanliness problems at several other pharmacies.
Article from http://www.nbcnews.com/health/fda-hopes-hospitals-will-switch-newly-regulated-pharmacies-2D11687779
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For nearly 20 years, Pharma Logistics has been helping retail pharmacies and hospitals maximize credit value for expired pharmaceuticals and stay compliant with federal and state regulations for disposal. To learn more about our pharmaceutical returns or waste management service, call us today at (888) 729-7427. Our three-step returns system and our highly trained staff makes the pharmaceutical returns process quick and easy.
If you have had a great experience at Pharma Logistics with any of our team members, please take the time to share your story with us through Facebookor our Review page.

Sales of leukemia chemotherapy drug suspended

Citing the risk of life-threatening blood clots and severe narrowing of blood vessels, FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of ponatinib (Iclusig).
Ariad has agreed to FDA’s request, and the agency is advising patients receiving ponatinib to speak with their physicians to discuss the risks and benefits of continuing to use the drug.
“We will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks,” a FDA spokesperson said.
According to an FDA investigation, approximately 24% of patients in the phase 2 clinical trial and approximately 48% of patients in the phase 1 clinical trial have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow.
FDA said it couldn’t identify a dose level or exposure duration for ponatinib that is safe.
FDA officials said patients who are currently taking ponatinib and responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks, should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues.
However, FDA said healthcare professionals should not start treating new patients with ponatinib unless no other treatment options are available and all other available therapies have failed.
Article from http://drugtopics.modernmedicine.com/drug-topics/news/sales-leukemia-chemotherapy-drug-suspended#%21
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For nearly 20 years, Pharma Logistics has been helping retail pharmacies and hospitals maximize credit value for expired pharmaceuticals and stay compliant with federal and state regulations for disposal. To learn more about our pharmaceutical returns or waste management service, call us today at (888) 729-7427. Our three-step returns system and our highly trained staff makes the pharmaceutical returns process quick and easy.
If you have had a great experience at Pharma Logistics with any of our team members, please take the time to share your story with us through Facebookor our Review page.